Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
72865–72888 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 28, 2003
COZART EIA COCAINE ORAL FLIUD KIT
K030234 · DIO
Cozart Bioscience , Ltd.
Toxicology · 95d
Cleared Apr 28, 2003
FLEXIBLE RUBBER ELECTRODES, MODELS: 1460265, 1460272, 1460274, 3444128,...
K030297 · GXY
Enraf-Nonius, B.V.
Neurology · 90d
Cleared Apr 28, 2003
DEROYAL GOWNS, STERILE, NON-STERILE
K030364 · FYA
Deroyal Industries, Inc.
General Hospital · 83d
Cleared Apr 28, 2003
QMS / MULTIGENT VALPROIC ACID REAGENT, PART #396075
K030405 · LEG
Seradyn
Toxicology · 81d
Cleared Apr 28, 2003
ROCHE ONLINE TDM PHENYTOIN
K030428 · DIP
Roche Diagnostics Corp.
Toxicology · 77d
Cleared Apr 28, 2003
SCULPTING RESIN
K030585 · EBD
Bisco, Inc.
Dental · 63d
Cleared Apr 28, 2003
MAS CHEMTRAK H & DADE MONI-TROL H LIQUID ASSAYED CHEMISTRY CONTROL
K030942 · JJY
Medical Analysis Systems, Inc.
Chemistry · 33d
Cleared Apr 28, 2003
MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL (EP) SYSTEM
K031009 · GWJ
Bio-Logic Systems Corp.
Neurology · 28d
Cleared Apr 28, 2003
THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY
K031028 · JEY
Bioplate, Inc.
Dental · 27d
Cleared Apr 28, 2003
ORTHOPEDIC WIRE
K031127 · JDR
Howmedica Osteonics Corp.
Orthopedic · 19d
Cleared Apr 25, 2003
APNEACHECK
K022294 · MNR
Im Systems
Anesthesiology · 283d
Cleared Apr 25, 2003
TRAVELSOME STANDARD
K030233 · CAW
Sim Italia S.R.L.
Anesthesiology · 92d
Cleared Apr 25, 2003
FLAT PANEL DISPLAY, ME183L
K030272 · LLZ
Totoku Electric Co., Ltd.
Radiology · 88d
Cleared Apr 25, 2003
MEDICAL FLAT PANEL DISPLAY, ME315L
K030274 · LLZ
Totoku Electric Co., Ltd.
Radiology · 88d
Cleared Apr 25, 2003
FLAT PANEL DISPLAYS, CDL SERIES
K030276 · LLZ
Totoku Electric Co., Ltd.
Radiology · 88d
Cleared Apr 25, 2003
MONOCANALICULAR STENTS, LACRIMAL INTUBATION SETS
K030353 · OKS
Eagle Vision, Inc.
Ophthalmic · 81d
Cleared Apr 25, 2003
BARE LASER FIBER MODELS DBLF-40, DBLF-60, DBLF-60-1, DCLF-600B, DSLF-60,...
K030959 · GEX
Laser Peripherals, LLC
General & Plastic Surgery · 29d
Cleared Apr 25, 2003
EXELTRA HIGH FLUX DIALYZER, MODELS 150 & 170
K030974 · KDI
Baxter Healthcare Corp
Gastroenterology & Urology · 28d
Cleared Apr 25, 2003
EXELTRA PLUS HIGH FLUX DIALYZER, MODEL 210
K030975 · KDI
Baxter Healthcare Corp
Gastroenterology & Urology · 28d
Cleared Apr 25, 2003
TRUFLOW DUAL-LUMEN POLYURETHANE LONG-TERM STRAIGHT DIALYSIS CATHETER (12.5 FR...
K030983 · MSD
Deltec, Inc.
Gastroenterology & Urology · 28d
Cleared Apr 24, 2003
ELOX P 45-BP
K023205 · DTB
Biotronik, Inc.
Cardiovascular · 211d
Cleared Apr 24, 2003
APPLANATION TONOMETER
K023676 · HKX
Optilasa, S.L.
Ophthalmic · 174d
Cleared Apr 24, 2003
AMATOMICAL SHOULDER WITH REMOVABLE HEAD
K030259 · KWS
Centerplus Orthopedics, Inc.
Orthopedic · 90d
Cleared Apr 24, 2003
BATTERY, RECHARGEABLE
K030261 · HGM
Access Battery, Inc.
Obstetrics & Gynecology · 90d